the peerless study

Conditions: Pulmonary Embolism; Pulmonary Thrombo-embolism

Summary: a prospective, multicenter, randomized controlled trial of the flowtriever system compared to catheter-directed thrombolysis (cdt) for use in the treatment of acute pulmonary embolism. the trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.


Eligibility criteria:
inclusion criteria subjects must meet each of the following criteria to be included in the study: * age ≥ 18 years * echo, computed tomographic pulmonary angiography (ctpa), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery * including all of the following: clinical signs and symptoms consistent with acute pe, or pesi class iii-v, or spesi ≥1; and hemodynamically stable and; rv dysfunction on echocardiography or ct; and any one or more of the following present at the time of diagnosis: elevated cardiac troponin levels; history of heart failure; history of chronic lung disease; heart rate ≥110 beats per minute; sbp \<100mmhg; respiratory rate ≥30 breaths per minute; o2 saturation \<90%; syncope related to pe; elevated lactate * intervention planned to begin within 72 hours of the later of either: confirmed pe diagnosis; or if transferring from another hospital, arrival at the treating hospital * symptom onset within 14 days of confirmed pe diagnosis exclusion criteria subjects will be excluded from the study for any of the following criteria: * unable to anticoagulate with heparin, enoxaparin or other parenteral antithrombin * index presentation with hemodynamic instability that are part of the high-risk pe definition in the esc guidelines 2019, including any of the following: cardiac arrest; or systolic bp \< 90 mmhg or vasopressors required to achieve a bp ≥90 mmhg despite adequate filling status, and end-organ hypoperfusion; or systolic bp \< 90 mmhg or systolic bp drop ≥40 mmhg, lasting longer than 15 min and not caused by new-onset arrhythmia, hypovolemia, or sepsis * known sensitivity to radiographic contrast agents that, in the investigator's opinion, cannot be adequately pre-treated * imaging evidence or other evidence that suggests, in the opinion of the investigator, the patient is not appropriate for catheter-based intervention (e.g. inability to navigate to target location, clot limited to segmental/subsegmental distribution, predominately chronic clot) * patient has right heart clot in transit identified at baseline screening * life expectancy \< 30 days (e.g. stage 4 cancer or severe covid-19 infection), as determined by the investigator * current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study * current or history of chronic thromboembolic pulmonary hypertension (cteph) or chronic thromboembolic disease (cted) diagnosis, per esc 2019 guidelines * invasive systolic pa pressure ≥70 mmhg prior to study device entering the body * administration of bolus or drip/infusion thrombolytic therapy or mechanical thrombectomy for the index pe event within 48 hours prior to enrollment * ventricular arrhythmias refractory to treatment at the time of enrollment * known to have heparin-induced thrombocytopenia (hit) * subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments). this includes a contraindication to use of flowtriever or cdt system (for example, ekos system) per local approved labeling * subject has previously completed or withdrawn from this study * patient unwilling or unable to conduct the follow up visits per protocol.

Keywords: pe pulmonary embolism thrombectomy flowtriever cdt catheter-directed thrombolysis